Global RA Consultancy Network
Connect with our trusted network of regulatory affairs consultancies specializing in medical device registration and compliance across major global markets.
Showing 5 of 5 consultancies
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Specializations
Languages: English, Japanese, Chinese (Mandarin & Cantonese), Korean, Thai, Vietnamese, Bahasa Indonesia, Bahasa Malaysia, German
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
Specializations
Languages: English, Chinese (Mandarin), Malay, Vietnamese, Thai, Korean, German
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
Specializations
Languages: Japanese, English, Chinese (Mandarin), Korean
EPSI GLOBAL PTE. LTD.
Singapore (HQ), Kuala Lumpur, Malaysia, Jakarta, Indonesia, Bangkok, Thailand, Hanoi, Vietnam, Manila, Philippines, Shanghai, China
We provide end-to-end regulatory solutions covering all classes of medical devices and IVDs in major APAC markets, especially the ASEAN region (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines) and major Northeast Asian markets (China, Korea, Japan). Services include classification, registration, local authorized representation, quality management system (QMS) implementation/auditing (ISO 13485/local GMP), and post-market surveillance. Their local presence minimizes market entry risks and time-to-market.
Specializations
Languages: English, Chinese (Mandarin), Malay, Vietnamese, Thai, Indonesian
Pacific Bridge Medical
USA, China, Japan, Singapore, Hong Kong, India (Affiliate), Indonesia (Affiliate), Korea (Affiliate), Malaysia (Affiliate), Philippines (Affiliate), Taiwan (Affiliate), Thailand (Affiliate), Vietnam (Affiliate)
A boutique consulting firm specializing in Asian medical and pharmaceutical regulatory affairs and business development. We provide comprehensive, on-the-ground support for market entry, registration, quality compliance, and local agent representation across 12 Asian markets.
Specializations
Languages: English, Japanese, Chinese (Mandarin & Cantonese), Korean, Thai, Vietnamese, Bahasa Indonesia, Bahasa Malaysia
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